ATROPOS: Survival Analysis of ICI-associated Myocarditis

NCT07633587 | Recruiting

• 1 other identifier: CIC2503-26-06
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

ATROPOS is an international, registry-based observational study of cancer patients with immune checkpoint inhibitor-associated myocarditis (ICI-M). The study evaluates whether immunosuppressive treatment strategies, including first-line glucocorticoids and subsequent second-line immunosuppressants, are associated with overall mortality, and whether these associations vary according to myocarditis severity. The target number of cases to be included is 1500 spanning from at least 160 centers, located in at least 18 countries. Analyses will adjust for clinically relevant confounders and may use time-dependent survival models where appropriate.

Conditions

Immune Checkpoint Inhibitor-associated Myocarditis

Keywords

immune checkpoint inhibitors; myocarditis; mortality; REDCap; myotoxicity

Outcome Measures

Primary Outcomes (1)

• All-cause mortality at 90 days after ICI-M presentation/index date

  Death from any cause within 90 days of ICI-M presentation/index date, analysed in relation to immunosuppressive treatment strategy and adjusted for prespecified confounders. Treatment and selected clinical variables may be handled as time-dependent covariates.

  90 days from ICI-M presentation/index date

Secondary Outcomes (2)

• All-cause mortality at 30 days and 360 days after ICI-M presentation/index date

  30 days and 360 days from ICI-M presentation/index date

• Modification of treatment-mortality association by myocarditis severity

  Up to 360 days from ICI-M presentation/index date

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cancer patients exposed to immune checkpoint inhibitors and recorded in a REDCap international ICI-Myocarditis registry, including cases with clinical, biomarker, ECG, imaging, treatment, complication and mortality/outcome data sufficient for the planned survival analyses.

You may qualify if:

• cancer patients exposed to at least one immune checkpoint inhibitor
• possible, probable or definite immune checkpoint inhibitor-associated myocarditis recorded in the international registry according to registry/adjudication definitions
• available index-date/presentation information
• available mortality follow-up.

You may not qualify if:

• duplicate records
• not enough data to classify as myocarditis

Sponsors & Collaborators

• Groupe Hospitalier Pitie-Salpetriere: lead
• Vanderbilt University Medical Center: collaborator

Study Sites (1)

Hopital Pitie-Salpetriere / CIC-2503

Paris, France

RECRUITING

MeSH Terms

Conditions

Myocarditis; Myotoxicity

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Central Study Contacts

Joe-Elie Salem, MD-PhD

CONTACT

0033142178531; joe-elie.salem@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, Clinical Investigation Center Paris Est

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 8, 2026
• Study Start: May 20, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: June 10, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)